Study to Evaluate Lenalidomide Plus Dexamethasone in Patients With Newly Diagnosed POEMS Syndrome

POEMS Syndrome Clinical Trial

Official title:

An Open-label Phase II Study to Determine the Efficacy and Safety of Lenalidomide Plus Dexamethasone (LDex) in Patients With Newly Diagnosed POEMS Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816620
• Other study ID #: POEMS-01
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2013
• Last updated: April 23, 2017
• Start date: March 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this prospective study is to determine the efficacy and safety of lenalidomide plus dexamethasone in patients with newly diagnosed POEMS syndrome.

Description:

The investigators propose to use the adverse effects as well as the need for dose reduction as a criterion to judge tolerability of treatment.

The primary endpoint would be hematological response rate according to international myeloma working group (IMWG) response criteria for amyloidosis and neurological response rate defined by overall neuropathy limitation scale (ONLS) score.

This study expects to enroll approximately 41 subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients must understand and voluntarily sign an informed consent form.

2. Older than 18 years old at the time of signing consent.

3. Meet the diagnostic criteria of POEM syndrome.

4. Must be cytotoxic treatment naive. However, previous or existing corticosteroid (prednisone or dexamethasone) or intravenous immunoglobin (IVIG) therapy is allowed.

5. Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.

6. Male subjects must agree to use condoms throughout study drug therapy.

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

2. Pregnant or lactating females.

3. Any of the following laboratory abnormalities:

Absolute neutrophil count(ANC) of<1.0×10E9 cell/L. Platelet count<50×10E9 cell/L. Renal failure requiring dialysis. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times of the normal upper limit.

4. Prior history of malignancies, but not including basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and T1a or T1b prostate cancer.

5. Known hypersensitivity or prior history of uncontrollable side effects to dexamethasone therapy.

6. Prior use of cytotoxic drugs.

7. Subjects who are unable or unwilling to undergo antithrombotic therapy.

Related Conditions & MeSH terms

• POEMS Syndrome
• Syndrome

Intervention

Drug:
• Lenalidomide, Dexamethasone
12 cycles of lenalidomide and dexamethasone, each cycle lasts 28 days. For patients with Ccr equal to or higher than 30ml/min, oral lenalidomide 10mg once daily for days 1-21 out of a 28 cycle. For patients with Ccr lower than 30ml/min, oral lenalidomide 10mg once every other day for days 1-21 out of a 28 cycle. All the patients take Dexamethasone orally 40mg once weekly for day 1,8,15,22 out of a 28 cycle.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Celgene Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematological response rate		last day of the LDx treatment regimen (up to 9 months)
Primary	Neurological response rate defined by ONLS score		last day of the LDx treatment regimen (up to 9 months)
Secondary	response rate of critical organs		every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months
Secondary	Response rate of serum vascular endothelial growth factor (VEGF) level		every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months
Secondary	Time to initial neurological response		every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months
Secondary	Overall survival		From date of first diagnosis until the date of death from any cause, otherwise patients will be censored in June, 2018 (up to 5 years)
Secondary	Relapse free survival		From date of first diagnosis until the date of first documented relapse or date of death from any cause, whichever came first, otherwise patients will be censored in June, 2018 (up to 5 years)
Secondary	adverse events		throughout the treatment and until 30 days after the administration of the last dose of a study drug
Secondary	time to the best neurological response		every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months